Executive Summary
From PC to CPV: Preserving Process Knowledge Through Late-Phase Tech Transfer
Abstract: Late-phase tech transfer is not about reinventing a process.
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Article
Why Comprehensive Analytical Services are Core to the Future of Antibody-Drug Conjugates
Abstract: As antibody-drug conjugates (ADCs) grow more complex, comprehensive analytical services are becoming central to successful development from discovery through commercialization.
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Webinars
Designed to Deliver: Workflow Solutions for Rapid Transient Production using GPEx® Lightning
Abstract: This webinar highlights Catalent’s GPEx® Lightning platform and transient expression capabilities, demonstrating how sponsors can accelerate biologics development while reducing time to critical decision points.
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Article
How To Structure an Analytical Services Partnership from Pre IND Through Commercial for ADCs
Abstract: Successful ADC development depends on an analytical strategy that addresses molecular complexity from the earliest stages and evolves through commercialization.
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Article
Navigating the Complexities of Cell and Gene Therapy Supply Chains
Abstract: Cell and gene therapy supply chains are uniquely complex, requiring precise coordination, regulatory compliance, and robust logistics to ensure timely delivery of life-saving treatments.
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Article
Selecting the optimal cell therapy manufacturing platform
Abstract: Choosing between modular and fully integrated manufacturing platforms is a critical decision for cell therapy developers, impacting scalability, cost efficiency, and commercial viability.
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Article
All about cell therapy process characterization
Abstract: Process characterization is essential for cell therapy programs, ensuring consistent, safe, and effective products that meet regulatory standards.
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White Papers
Can Advanced Analytics with Data-Driven Manufacturing Power Up Cell Therapy
Abstract: Cell therapies have complex manufacturing needs since the final drug product is viable cells comprising thousands of proteins, lipids and carbohydrates that can change with every manipulation step.
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Article
Why it’s critical to close open steps in cell therapy manufacturing
Abstract: Open steps in cell therapy manufacturing expose products to contamination risk, operational complexity, and scalability limitations.
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Article
Building a robust in-process testing plan for cell therapy manufacturing success
Abstract: Cell therapy manufacturing demands rigorous quality control, as living cell products cannot be terminally sterilized and are often produced in small batches.
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